MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510870

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

Exact patient age unknown, but reported to be over 18 years of age.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noted the side car was kinked and pushed back.The procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract during a stone removal procedure performed on (b)(6), 2019.According to the complainant, during preparation, it was noted the side car was kinked and pushed back.The procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block a2: exact patient age unknown, but reported to be over 18 years of age.Block h6: problem code 2976 captures the reportable event of side car rx - push back.Block h10: visual inspection of the returned device found the side car-rx was pushed back out of specification.The working length (sheath and coil assembly) was bent at the distal section.Based on all available information, it is most likely that handling and manipulation of the device during unpacking/prepping/testing can lead to pushed back of the side car and working length bent.Also,interaction with other devices could have contributed to side car pushed back and working length bent.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9485193
• MDR Text Key: 189838498
• Report Number: 3005099803-2019-06163
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0023888824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1